Associate Director, Risk Based Quality Management, Oncology

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

This position reports to the Executive Director, Data Management, Oncology and is part of the Data Management Oncology organization, which supports high-quality clinical trial execution through data oversight, risk identification, documentation, analytics, and cross-functional study support. The role is responsible for providing study-level leadership for Risk Based Quality Management (RBQM) across Phase 1 to Phase 4 oncology clinical trials and works closely with Clinical Operations, Data Management, Biostatistics, Clinical Project Teams, Quality, and other partner functions to ensure proactive risk assessment, centralized monitoring, mitigation planning, inspection readiness, and aligned execution of SMPA RBQM strategy.

Essential Functions Required for Job

• Facilitate understanding and adoption of the SMPA RBQM strategy within Clinical Project Teams by providing targeted training, practical guidance, and cross-functional alignment.
• Lead and facilitate cross-functional study risk assessment meetings, including planning, meeting facilitation, documentation of decisions, and follow-through on mitigation actions.
• Own the development, maintenance, and periodic update of Risk Assessment Categorization Tools (RACTs), Quality Risk Management Plans (QRMPs), and related quality parameter documentation for assigned studies.
• Ensure functional study plans align with approved risk assessments, Critical to Quality (CtQ) factors, protocol requirements, quality parameters, and data quality objectives.
• Partner with Data Management, Biostatistics, Clinical Operations, and other functional stakeholders to define, implement, monitor, interpret, and escalate key risk indicators (KRIs), quality tolerance limits (QTLs), and centralized monitoring outputs.
• Lead centralized monitoring activities, including ongoing data review, signal detection, trend analysis, documentation of findings, risk escalation, mitigation planning, and follow-through with accountable stakeholders.
• Provide expert guidance on targeted source data verification (SDV) and targeted source data review (SDR) approaches based on evolving risk profiles and study-level quality signals.
• Interpret clinical and operational datasets to identify emerging risks, quality trends, and areas requiring mitigation, escalation, or further cross-functional review.
• Develop and deliver risk analytics, dashboards, trend summaries, and leadership-ready presentations for Clinical Project Teams and functional leadership.
• Act as the RBQM subject matter expert within Data Management, providing consultation, standards interpretation, and practical guidance to cross-functional stakeholders.
• Support inspection readiness by ensuring RBQM rationale, review decisions, escalation records, mitigation documentation, and quality oversight outputs are complete, traceable, and defensible.
• Contribute to continuous improvement of RBQM processes, tools, templates, technology strategy, standards, and related SOP implementation across Data Management.
• Maintain proficiency in RBQM systems, centralized monitoring platforms, data access tools, dashboards, analytics, and applicable technology used to support risk-based oversight.
• Serve as business lead or functional representative for assigned RBQM-related technology, process improvement, or enterprise-level initiatives as needed.
• Manage direct reports, including workload planning, prioritization, coaching, performance feedback, development planning, and support for successful execution of responsibilities.

Knowledge, Skills and Abilities (general & technical):

• Strong knowledge of RBQM principles, quality risk management, centralized monitoring, clinical data review, and TransCelerate RBQM concepts including RACT and QRMP.
• Demonstrated ability to facilitate risk discussions, synthesize cross-functional input, document decisions clearly, and drive alignment in a matrixed environment.
• Strong analytical skills with the ability to interpret clinical and operational data, identify meaningful trends, and translate findings into practical mitigation recommendations.
• Working knowledge of KRIs, QTLs, CtQ factors, targeted SDV, targeted SDR, clinical trial quality oversight, and inspection readiness expectations.
• Excellent written and verbal communication skills, including ability to develop clear documentation, dashboards, presentations, and leadership-level summaries.
• High degree of organizational awareness, with the ability to connect related activities, understand interdependencies, and anticipate downstream impacts across study teams and functions.
• Strong stakeholder management, facilitation, prioritization, problem-solving, and decision-making skills.
• Attention to detail and ability to maintain traceable, audit-ready documentation of risk assessments, quality parameters, mitigation decisions, and study-level oversight activities.
• Ability to coach and develop team members, provide actionable feedback, and support team members in navigating priorities and cross-functional accountabilities.
• Proficiency with Microsoft Office applications and familiarity with clinical data systems, centralized monitoring tools, reporting platforms, and data visualization tools.

Education & Experience Requirements:

• Bachelor's degree in life sciences, data analytics, technology, clinical research, or a related field required; advanced degree preferred.
• Minimum 8 years of relevant experience in the biotech or pharmaceutical industry with a Bachelor’s Degree, consistent with the Associate Director job level requirement.
• Progressive experience in clinical development, data management, clinical quality, clinical operations, RBQM, or related clinical trial oversight roles.
• Demonstrated experience supporting or leading oncology clinical trials across Phase 1 to Phase 4.
• Hands-on experience with RBQM frameworks, including RACT and QRMP development, maintenance, governance, and cross-functional review.
• Experience implementing or supporting centralized monitoring, KRIs, QTLs, trend analysis, risk escalation, and targeted SDV/SDR strategies.
• Experience supporting regulatory inspections, audits, quality reviews, or inspection readiness activities related to RBQM, clinical quality oversight, or data management.
• Preferred qualifications include experience contributing to functional, technology, or enterprise-level RBQM initiatives and continuous improvement efforts.

Other Requirements (licenses, certifications, specialized training, and physical or mental abilities required):

• No specific license required. RBQM, clinical quality, GCP, data analytics, or clinical research certifications or specialized training are preferred.
• Requires ability to exercise sound judgment, manage competing priorities, work independently, and collaborate effectively with cross-functional stakeholders in a fast-paced environment.
• Requires ability to use a personal computer and business systems for extended periods of time.

Travel Requirements:

• Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

• Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management

• This position includes people-management responsibilities, including day-to-day supervision, workload planning, coaching, performance feedback, development planning, and ensuring team members have the resources and support needed to succeed.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

The base salary range for this role is

$164,600.00 - $205,700.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.